The Biomarker Exploratory Study in Prospective Multicenter Observational Study of Atezolizumab Combination Therapy in Lung Cancer (J-TAIL-2)

The Exploratory Study to Evaluate Biomarkers in Prospective Multicenter Observational Study of Atezolizumab Combination Therapy in Patients With Unresectable, Advanced and Recurrent Non-small Cell Lung Cancer or Extensive Disease Small Cell Lung Cancer (J-TAIL-2)

This study is implemented in association with the study "J-TAIL-2" ; prospective multicenter observational study of atezolizumab in patients with unresectable, locally advanced or metastatic non-small cell lung cancer, UMIN study ID: UMIN000041263, to evaluate biomarkers for selection of appropriate patients in treatment with atezolizumab combination therapy.

Study Overview

• Status: Completed
• Conditions: Non-small Cell Lung Cancer; Extensive Disease Small Cell Lung Cancer

• Study Type: Observational
• Enrollment (Actual): 470

Contacts and Locations

• Study Contact: Name: J-TAIL-2 study executive office; Phone Number: +81-3-5804-5045; Email: prj-jtail2@eps.co.jp

Study Locations

• Japan
  • Akashi, Japan
    • Hyogo Cancer Center
  • Asahikawa, Japan
    • Asahikawa Medical University Hospital
  • Asahikawa, Japan
    • National Hospital Organization Asahikawa Medical Center
  • Bunkyō-Ku, Japan
    • Juntendo University Hospital
  • Bunkyō-Ku, Japan
    • Nippon Medical School Hospital
  • Bunkyō-Ku, Japan
    • Tokyo Medical and Dental University, Medical Hospital
  • Chiba, Japan
    • Chiba University Hospital
  • Chuo Ku, Japan
    • National Cancer Center Hospital
  • Fukuoka, Japan
    • Fukuoka University Hospital
  • Fukuoka, Japan
    • National Hospital Organization Kyushu Cancer Center
  • Fukuoka, Japan
    • National Hospital Organization Kyushu Medical Center
  • Fukushima, Japan
    • Fukushima Medical University Hospital
  • Ginowan, Japan
    • National Hospital Organization Okinawa National Hospital
  • Himeji, Japan
    • National Hospital Organization Himeji Medical Center
  • Hirakata, Japan
    • Kansai Medical University Hospital
  • Hirosaki, Japan
    • Hirosaki University Hospital
  • Hiroshima, Japan
    • Hiroshima University Hospital
  • Iizuka, Japan
    • Aso Iizuka Hospital
  • Inzai, Japan
    • Nippon Medical School Chiba Hokusoh Hospital
  • Isehara, Japan
    • Tokai University Hospital
  • Itabashi-Ku, Japan
    • Teikyo University Hospital
  • Itami, Japan
    • Itami City Hospital
  • Iwakuni, Japan
    • National Hospital Organization Iwakuni Clinical Center
  • Izumo, Japan
    • Shimane University Hospital
  • Kagawa, Japan
    • Kagawa University Hospital
  • Kagoshima, Japan
    • Kagoshima University Hospital
  • Kanazawa, Japan
    • Kanazawa University Hospital
  • Kasukabe, Japan
    • Kasukabe Medical Center
  • Kitakyushu, Japan
    • Kitakyushu Municipal Medical Center
  • Kitakyushu, Japan
    • Hospital of the University of Occupational and Envioronmental Health
  • Kiyose, Japan
    • Japan Anti-Tuberculosis Association Fukujuji Hospital
  • Kobe, Japan
    • Kobe University Hospital
  • Kobe, Japan
    • Kobe Minimally Invasive Cancer Center
  • Koto-Ku, Japan
    • The Cancer Institute Hospital of Japanese Foundation for Cancer Research
  • Kurume, Japan
    • Kurume University Hospital
  • Kyoto, Japan
    • Kyoto University Hospital
  • Kyoto, Japan
    • University Hospital, Kyoto Prefectural University of Medicine
  • Kyoto, Japan
    • Kyoto City Hospital
  • Matsumoto, Japan
    • Shinshu University Hospital
  • Matsusaka, Japan
    • Matsusaka Municipal Hospital
  • Meguro-Ku, Japan
    • National Hospital Organization Tokyo Medical Center
  • Minato-Ku, Japan
    • The Jikei University Hospital
  • Miyazaki, Japan
    • Miyazaki Prefectural Miyazaki Hospital
  • Nagakute, Japan
    • Aichi Medical University Hospital
  • Nagasaki, Japan
    • Nagasaki University Hospital
  • Nagoya, Japan
    • Nagoya University Hospital
  • Nagoya, Japan
    • Nagoya City University Hospital
  • Nagoya, Japan
    • Aichi Cancer Center
  • Nagoya, Japan
    • National Hospital Organization Nagoya Medical Center
  • Natori, Japan
    • Miyagi Cancer Center
  • Niigata, Japan
    • Niigata Cancer Center Hospital
  • Niigata, Japan
    • Niigata University Medical and Dental Hospital
  • Nishinomiya, Japan
    • The Hospital of Hyogo College of Medicine
  • Obihiro, Japan
    • Obihiro Kosei Hospital
  • Okayama, Japan
    • Okayama University Hospital
  • Okayama, Japan
    • Japanese Red Cross Okayama Hospital
  • Okayama, Japan
    • Kawasaki Medical School General Medical Center
  • Okayama, Japan
    • Okayama Rosai Hospital
  • Osaka, Japan
    • Osaka City General Hospital
  • Osaka, Japan
    • Osaka International Cancer Institute
  • Osaka, Japan
    • Osaka General Medical Center
  • Saitama, Japan
    • Saitama Prefectural Cancer Center
  • Saitama, Japan
    • Saitama Medical University International Medical Center
  • Saitama, Japan
    • Saitama Red Cross Hospital
  • Sakai, Japan
    • National Hospital Organization Kinki-Chuo Chest Medical Center
  • Sapporo, Japan
    • Hokkaido University Hospital
  • Sapporo, Japan
    • Teine Keijinkai Hospital
  • Sendai, Japan
    • Tohoku University Hospital
  • Sendai, Japan
    • Sendai Kousei Hospital
  • Sendai, Japan
    • Tohoku Medical and Pharmaceutical University Hospital
  • Shinagawa-Ku, Japan
    • Showa University Hospital
  • Shinjuku-Ku, Japan
    • Keio University Hospital
  • Shinjuku-Ku, Japan
    • Center Hospital of the National Center for Global Health and Medicine
  • Shiwa-gun, Japan
    • Iwate Medical University Hospital
  • Suita, Japan
    • Osaka University Hospital
  • Suita, Japan
    • Saiseikai Suita Hospital
  • Takamatsu, Japan
    • Kagawa Prefectural Central Hospital
  • Takaoka, Japan
    • JA Toyama Kouseiren Takaoka Hospital
  • Takarazuka, Japan
    • Takarazuka City Hospital
  • Takatsuki, Japan
    • Osaka Medical and Pharmaceutical University Hospital
  • Tenri, Japan
    • Tenri Hospital
  • Tochigi, Japan
    • Dokkyo Medical University Hospital
  • Tokushima, Japan
    • Tokushima University Hospital
  • Tokushima, Japan
    • Tokushima Prefectural Central Hospital
  • Toyama, Japan
    • Toyama Prefectural Central Hospital
  • Toyoake, Japan
    • Fujita Health University Hospital
  • Ube, Japan
    • National Hospital Organization Yamaguchi-Ube Medical Center
  • Wakayama, Japan
    • Wakayama Medical University Hospital
  • Yokohama, Japan
    • Yokohama City University Hospital
  • Yokohama, Japan
    • Kanagawa Cardiovascular and Respiratory Center
  • Yonago, Japan
    • Tottori University Hospital
  • Yufu, Japan
    • Oita University Hospital
  • Ōsaka-sayama, Japan
    • Kindai University Hospital
  • Ōta, Japan
    • Gunma Prefectural Cancer Center
  • Ōtsu, Japan
    • Shiga University of Medical Science Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who are planning to provide atezolizumab combination therapy as the most appropriate medical care for patients and who meet the Eligibility criteria at registration.

Description

Inclusion Criteria:

Inclusion/exclusion criteria of J-TAIL-2 study is to be applied.

<non-small cell lung cancer cohort>

1. Patients 20 years of age or older at the time of signed consent.
2. Patients with unresectable, advanced and recurrent non-small cell lung cancer.
3. Patients who are scheduled to start atezolizumab combination therapy in clinical practice, based on the atezolizumab package insert and the Optimal Clinical Use Guideline.
4. Patients who signed informed consent form before enrolling the study. The consent from a legally acceptable representative is required for the patients with uncertain capacity of judgments.

<extensive disease small cell lung cancer cohort>

1. Patients 20 years of age or older at the time of signed consent.
2. Patients with extensive disease small cell lung cancer.
3. Patients who are scheduled to start atezolizumab combination therapy in clinical practice, based on the atezolizumab package insert and the Optimal Clinical Use Guideline.
4. Patients who signed informed consent form before enrolling the study. The consent from a legally acceptable representative is required for the patients with uncertain capacity of judgments. However, the samples of dead cases can be used for the analysis of immune microenvironment of small cell lung cancer by disclosing information on this study.

Exclusion Criteria:

<non-small cell lung cancer cohort>

1. Patients who are unsuitable for enrolment into the study by the investigator's judgment.

<extensive disease small cell lung cancer cohort>

1. Patients who are unsuitable for enrolment into the study by the investigator's judgment.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
NSCLC cohort; Patients with locally advanced or metastatic non-small cell lung cancer who are planning to provide atezolizumab combination therapy as the most appropriate medical care
ED-SCLC cohort; Patients with extensive disease small cell lung cancer who are planning to provide atezolizumab combination therapy as the most appropriate medical care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Correlation between PD-L1 SNP and atezolizumab combination therapy	Baseline
Correlation between rate of change in plasma protein expression level and atezolizumab combination therapy	Baseline, Predose of cycle 2 (each cycle is 21 days), and when immune-related adverse event occurs (through study completion, an average of 2 years 5 months)
Correlation between an immune microenvironment of small cell lung cancer and atezolizumab combination therapy	Baseline

Collaborators and Investigators

• Sponsor: Chugai Pharmaceutical
• Collaborators: Japan Lung Cancer Society
• Investigators: Principal Investigator: Akihiko GENMA, Nippon Medical School

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2021
• Primary Completion (Actual): February 3, 2023
• Study Completion (Actual): February 3, 2023

Study Registration Dates

• First Submitted: March 19, 2021
• First Submitted That Met QC Criteria: March 24, 2021
• First Posted (Actual): March 26, 2021

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Atezolizumab
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma
• Other Study ID Numbers: J-TAIL-2 biomarkers

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that underlie results in a publication.
• IPD Sharing Time Frame: After the end of the study
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No